HELIOS Advanced: Human Embryo Illumination to Enhance Development (HELIOS-A)
HELIOS Advanced: 인간 난자 조명을 통한 발달 향상
As women get older, the "power plants" of the cells (called mitochondria) don't work as well. This makes it harder for eggs and embryos to develop normally. One possible way to help is with a gentle light treatment called photobiomodulation (PBM). This uses a special type of red light that boosts energy production in cells and helps them stay healthy. This study will test whether adding this light treatment during in vitro fertilization (IVF) can improve embryo growth and pregnancy outcomes.
연구 개요
상세 설명
Embryo development is highly energy-dependent, and impaired mitochondrial function is a well-established hallmark of reproductive aging. As women age, reactive oxygen species (ROS) accumulate and cause mitochondrial DNA (mtDNA) damage, leading to reduced oxidative phosphorylation, ATP (Adenosine 5'-triphosphate) depletion, and developmental arrest of embryos. Enhancing mitochondrial function represents a promising strategy to improve embryo quality, particularly in women of advanced maternal age.
Photobiomodulation (PBM), also known as low-level light therapy (LLLT), involves the application of low-intensity red or near-infrared (NIR) light to modulate mitochondrial activity. NIR light specifically activates cytochrome c oxidase, leading to increased ATP production, reduced oxidative stress, and improved cellular resilience. Numerous preclinical studies, including isolated mitochondria, cell cultures, and in vivo animal models, have confirmed the safety and efficacy of NIR light in restoring mitochondrial function without inducing DNA damage or chromosomal abnormalities.
The investigators previously conducted IRB-approved laboratory studies using mouse and donated human embryos, demonstrating that brief exposure to PBM improved blastocyst formation without adversely affecting chromosomal status.
The current study builds upon this foundational work to evaluate the clinical impact of PBM at the oocyte stage. In a randomized, blinded, sibling-embryo design, the investigators will test whether PBM improves fertilization rates, blastocyst formation, embryo quality, and pregnancy outcomes in participants undergoing IVF or ICSI (Intracytoplasmic sperm injection) with PGT-A (preimplantation genetic testing for aneuploidy) using their autologous oocytes.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Samuel Zev Williams, MD, PhD
- 전화번호: 646-756-8282
- 이메일: zw2421@cumc.columbia.edu
연구 장소
-
-
New York
-
New York, New York, 미국, 10019
- 모병
- Columbia University Fertility Center
-
수석 연구원:
- Samuel Z Williams, MD, PhD
-
연락하다:
- Stephanie Morgan, MS
- 전화번호: 646-756-8282
- 이메일: sm3415@cumc.columbia.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female age between 18-48 years at the time of the IVF/ICSI cycle
- Undergoing blastocyst culture
- Using own oocytes
- Has at least two cleavage stage embryos available for randomization on Day 3 of embryo development
- Consenting to embryo level randomization
- Plan to transfer euploid embryo within 6 months
Exclusion Criteria:
- Use of donor oocytes or gestational carrier
- Concurrent experimental laboratory inventions outside of protocol
- Refusal of randomization or request for non-standard handling
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: No photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to not receive PBM. |
|
|
실험적: Photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to receive PBM. |
Photobiomodulation (PBM): also known as low-level light therapy (LLLT), involves the application of low-intensity red or near-infrared (NIR) light to modulate mitochondrial activity. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of usable blastocysts
기간: Seven days post egg retrieval
|
Usable blastocysts are defined as blastocysts that can be biopsied and frozen on Day 5, 6, or 7 of development for PGT-A (pre-implantation genetic testing for aneuploidy). The study will calculate the usable blastocyst rate per oocyte retrieved defined as the number of usable blastocysts per cleavage stage embryo on Day 3. |
Seven days post egg retrieval
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to 2-cell stage
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 2-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to 3-cell stage
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 3-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to 6-cell stage
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 6-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to 8-cell stage
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 8-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to morula
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the morula stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to start of blastulation
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to start blastulation from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to blastocyst
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to hatching blastocyst
기간: Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the hatching blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Number of good quality blastocysts as defined by Gardner grading system
기간: Up to seven days post egg retrieval
|
Final blastocyst quality at the time of cryopreservation (Day 5,6, or 7) will be assessed using the Gardner grading system, which consists of three parameters: expansion and hatching status (graded 1-6), inner cell mass (graded A-D), and trophectoderm (graded A-D). A good quality blastocyst will be defined as a blastocyst of grade 3BB or higher. |
Up to seven days post egg retrieval
|
|
Euploidy Rate
기간: Within 30 days post egg retrieval
|
The chromosomal ploidy status of cryopreserved blastocysts is assessed by the presence of two copies of each autosome and the expected complement of sex chromosomes. The euploidy rate is defined as the number of cryopreserved blastocysts that have the correct number of chromosomes divided by the total number of cryopreserved blastocysts. |
Within 30 days post egg retrieval
|
|
Proportion of Embryo Selected for Transfer
기간: Within 1 year post egg retrieval
|
In cases with no stated embryo sex preference, the proportion of cycles in which the embryo selected for transfer is from the PBM-treated group versus the control group will be reported. |
Within 1 year post egg retrieval
|
|
Implantation Rate
기간: Within 1 year post egg retrieval
|
Implantation rate is defined as the number of cycles with positive beta hCG (human chorionic gonadotropin) nine days or more post frozen embryo transfer divided by the total number of frozen embryo transfer cycles. |
Within 1 year post egg retrieval
|
|
Clinical pregnancy rate
기간: Within 1 year post egg retrieval
|
Clinical pregnancy rate is defined as the number of cycles with the presence of a gestational sac visualized on transvaginal ultrasound divided by the total number of frozen embryo transfer cycles. |
Within 1 year post egg retrieval
|
|
Miscarriage rate
기간: Within 1 year of egg retrieval
|
Miscarriage rate is defined as the number of cycles with clinical pregnancy losses divided by the number of cycles that had positive hCGs post frozen embryo transfer. |
Within 1 year of egg retrieval
|
|
Live birth rate
기간: Up to 2 years post egg retrieval
|
Live birth rate is defined as the number of cycles with a live born infant after 24 weeks gestation divided by total number of frozen embryo transfer cycles. |
Up to 2 years post egg retrieval
|
|
Gestational Age at Delivery
기간: Up to 2 years post egg retrieval
|
Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date. |
Up to 2 years post egg retrieval
|
|
Birthweight
기간: Up to 2 years post egg retrieval
|
The weight of the baby at birth in grams |
Up to 2 years post egg retrieval
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Samuel Zev Williams, MD/PhD, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .